Medical Director or Clinical Research Director
Company: Sanofi Group
Location: Honolulu
Posted on: May 28, 2023
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Job Description:
Job summary and key strategic intent
The Medical Director manages the clinical development of drug
candidates, medical monitoring of trials, including first in human
phase I-II studies primarily in oncology. The Medical Director will
have a solid understanding of all phases of early pharmaceutical
drug product development, including clinical trial management, IND
and CTA submissions, medical monitoring, GCP principles, and will
have experience in collaboration with Clinical Science, Clinical
Operations, Research and Clinical Pharmacology, Regulatory Affairs
and other key stakeholders.
The role requires strong subject matter expertise and/or ability to
independently research the area of study, and is a well-organized,
strategic focused, resourceful individual with excellent emotional
intelligence, self-motivation and ability to operate at a "hands
on" level and leads trial conduct with ease and
authenticity.
Serve as Medical lead on one or more early preclinical/clinical
molecules within the Amunix pipeline from and able to apply
clinical relevance and translation from preclinical data as
projects move from Phase I through proof of concept.
Serve as Medical lead on individual clinical trials in partner with
Clinical Science, Clinical Operations, Drug Safety and other key
stakeholders
Contribute to strategic and scientific discussions on related
projects and technologies within the Clinical Development team.
Key individual duties, responsibilities
Contribute to clinical development planning and clinical
strategy
Work with academic leaders/advisers to develop clinical
strategy
Provides clinical leadership and medical strategic input for all
clinical deliverables in the assigned project or section of a
clinical program if applicable
Develop protocols to execute clinical development strategies
Clinical deliverables may include clinical sections of individual
protocols, clinical data review, program specific standards,
clinical components of regulatory documents/registration dossiers,
and publications
Review all key documentation such as IND/CTA, health authority
communications and other documents (DUSR, INDAR, DRMP, RMP, etc),
protocols and amendments
Leads development of clinical sections of trial and program level
regulatory documents (e.g., Investigator's Brochures, briefing
books, safety updates, submission dossiers, and responses to Health
Authorities) and supports all other Regulatory activities and NDA
related questions
Work cooperatively with Clinical Operations and designated CROs to
execute the programs (e.g. lead study start up and database lock,
performs data and coding reviews; draft/present clinical slides for
Investigators Meeting, Advisory Boards and therapeutic/monitor
training; review draft CRFs, etc.)
Drives execution of the section of the clinical program in
partnership with other line functions (regulatory, clin ops)
Act as study medical monitor ensuring overall safety of the
molecule for the assigned section, and supports overall program
safety reporting (e.g., Periodic Safety Update Reports (PSURs),
Drug Safety Update Reports (DSURs), and other safety related
documents) in collaboration with Patient Safety
Consistently complies with, and ensures the compliance from direct
reports, of all governing laws, regulations, Amunix Standard
Operating Procedures (SOPs) and other guidelines
Keeps abreast of the highest standards and levels of scientific and
clinical knowledge in relevant therapeutic and disease area(s).
Review all data generated across the program to update strategy and
risk assessment
Regular review of competitive intelligence to update risk,
differentiation and valuation of program
Collaborates with Sanofi and external partners, regulators, and
diverse internal stakeholders and collaborators
Other duties commensurate with position as assigned
Ability to travel required
Skills, competencies required
Experience with pharmaceutical product development collectively
through clinical science or clinical trial conduct
Expertise in clinical development and methodology of clinical
studies and GCP principles
Ability to adapt and learn quickly in new areas of research,
clinical development, and have resourcefulness to independently
gather relevant information
Independent creative thinking related to overcoming hurdles and
problems.
Excellent communication skills (verbal and written) for
interactions across functional areas and for interactions with
investigators, key regulatory agencies
Demonstrated capability to challenge decision and status quo with a
risk-management approach
International/ intercultural working skills
Education and background
M.D. degree with a minimum of 5 years industry experience, or
comparable experience in academia
Demonstrated ability to independently evaluate, interpret and
present complex scientific data
Demonstrated ability to critically evaluate complex drug
development programs
Demonstrated ability to work within a multi-disciplinary team of
peers and outside experts
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and
Affirmative Action employers committed to a culturally diverse
workforce. All qualified applicants will receive consideration for
employment without regard to race; color; creed; religion; national
origin; age; ancestry; nationality; marital, domestic partnership
or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.
The salary range for this positio n is $ 135,515.63 - 180,687.50 to
$ 225,859.38 . All compensation will be determined commensurate
with demonstrated experience. Employees may be eligible to
participate in Company employee benefit programs. Additional
benefits information can be found through the link,
www.benefits.sanofiusallwell.com
As a healthcare company and a vaccine manufacturer, Sanofi has an
important responsibility to protect individual and public health.
All US based roles require individuals to be fully vaccinated
against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be "fully
vaccinated" fourteen (14) days after receiving (a) the second dose
of the Moderna or Pfizer vaccine, or (b) the single dose of the
J&J vaccine. Fully vaccinated, for new Sanofi employees, is to
be fully vaccinated 14 DAYS PRIOR TO START DATE.
#GD-SA
#LI-SA
At Sanofi diversity and inclusion is foundational to how we operate
and embedded in our Core Values. We recognize to truly tap into the
richness diversity brings we must lead with inclusion and have a
workplace where those differences can thrive and be leveraged to
empower the lives of our colleagues, patients and customers. We
respect and celebrate the diversity of our people, their
backgrounds and experiences and provide equal opportunity for
all.
Keywords: Sanofi Group, Honolulu , Medical Director or Clinical Research Director, Executive , Honolulu, Hawaii
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